{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "San Clemente",
      "address_1": "951 Calle Amanecer",
      "reason_for_recall": "The infusion sets were manufactured with an incorrect spin collar.",
      "address_2": "",
      "product_quantity": "550 pouches",
      "code_info": "Lot number 3533699, UDI (01) 0 0887709 09040 8 (17) 220901 (30) 01 (10)  3533699, and lot number 3549590, UDI   (01) 0 0887709 09040 8 (17) 221001 (30) 01 (10)  3549590.",
      "center_classification_date": "20180410",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) to state in AZ, CA, CO,  FL, SC, and TX; and countries of: Canada and Japan.",
      "state": "CA",
      "product_description": "6.5\" (17 cm) Appx. 0.57 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, NanoClave¿ T-Connector, 4 Clamps, Rotating Luer, Item A1254, 50 pouches per case, Sterile, Rx.  The firm name on the label is icumedical, San Clemente, CA.     The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).",
      "report_date": "20180418",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "ICU Medical, Inc.",
      "recall_number": "Z-1343-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "79077",
      "termination_date": "20190917",
      "more_code_info": "",
      "recall_initiation_date": "20180205",
      "postal_code": "92673-6212",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}